Non-Alcoholic Fatty Liver DiseaseNCT05890365
Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
An observational study of Non-Alcoholic Fatty Liver Disease and Low Birth Weight, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 34 to 49 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Low Birth Weight
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 49 years
- All sexes
- Adult
Study population: Healthy men and women aged between 34-49 years born with a low (cases) and normal (controls) birth weight. All individuals have to be born at term in either the Copenhagen or Aarhus area.
Who may be able to join
- 250 healthy, men and women born with a low birth weight (birth weight (BW) <10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population)
- born at term (weeks 39-41)
Who cannot join
- BMI>35 kg/m2
- Disease/medication known to affect primary outcome
- Self-reported high physical activity level
- Alcohol intake above general recommendations.
- Metabolic/liver disease
- Weight gain/loss of >3 kg within the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Charlotte Brøns, Phd, +4526129093, charlotte.broens.01@regionh.dk
Allan Vaag, MD, PhD, +4520429660, allan.arthur.vaag@regionh.dk
About this study
Official title: Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.
Read the detailed description
An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. Here we aim to perform an extended nested case-control screening study to evaluate hepatic steatosis (NAFLD) and fibrosis in early middle-aged, non-obese LBW men and women and NBW controls. In total, 250 LBW men and women (birth weight (BW) <10% of the population) and 50 NBW controls (BW between 50-90% of the population) born at term (weeks 39-41), 34-49 years-of-age will be recruited from the National Danish Birth Registry for the nested case-control NAFLD screening study. The nested case-control NAFLD screening study will serve as a recruitment platform for a subsequent intervention study.
- Keywords
- Metabolic disease, Adipose tissue biology, Liver fat, Non-alcoholic fatty liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Diseases, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
Liver elastography (FibroScan) and validation by MRS
Measured: 0 minutes
Secondary outcomes (6)
Liver fibrosis
Liver elastography, validation by MR and liver histology
Measured: 0 minutes
Body composition
DEXA
Measured: 0 minutes
Fasting glucose
mmol/l
Measured: 0 minutes
Fasting insulin/C-peptide
pmol/l
Measured: 0 minutes
Fasting lipids
mmol/l
Measured: 0 minutes
Fasting liver enzymes
U/L
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start14 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Lund University
- Responsible party
- Principal investigator, Charlotte Brøns, Steno Diabetes Center Copenhagen
- Investigators
- Allan Vaag, MD, PhD, Study director, Steno Diabetes Center CopenhagenCharlotte Brøns, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890365
- Sponsor's protocol ID
- NAFLD validation
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.
- ClinicalTrials.gov ID
- NCT05890365
- Acronym / sponsor ID
- NAFLD validation
- Keywords
- Metabolic disease, Adipose tissue biology, Liver fat, Non-alcoholic fatty liver disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Lund University
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.
Detailed description
An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. Here we aim to perform an extended nested case-control screening study to evaluate hepatic steatosis (NAFLD) and fibrosis in early middle-aged, non-obese LBW men and women and NBW controls. In total, 250 LBW men and women (birth weight (BW) <10% of the population) and 50 NBW controls (BW between 50-90% of the population) born at term (weeks 39-41), 34-49 years-of-age will be recruited from the National Danish Birth Registry for the nested case-control NAFLD screening study. The nested case-control NAFLD screening study will serve as a recruitment platform for a subsequent intervention study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 34 to 49 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy men and women aged between 34-49 years born with a low (cases) and normal (controls) birth weight. All individuals have to be born at term in either the Copenhagen or Aarhus area.
Key inclusion criteria (2 listed)
- 250 healthy, men and women born with a low birth weight (birth weight (BW) <10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population)
- born at term (weeks 39-41)
Key exclusion criteria (6 listed)
- BMI>35 kg/m2
- Disease/medication known to affect primary outcome
- Self-reported high physical activity level
- Alcohol intake above general recommendations.
- Metabolic/liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver fat content
Time frame: 0 minutes
Liver elastography (FibroScan) and validation by MRS
6 secondary outcomes
Liver fibrosis
Time frame: 0 minutes
Body composition
Time frame: 0 minutes
Fasting glucose
Time frame: 0 minutes
Fasting insulin/C-peptide
Time frame: 0 minutes
Fasting lipids
Time frame: 0 minutes
Fasting liver enzymes
Time frame: 0 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allan Vaag, MD, PhD study director
Steno Diabetes Center Copenhagen
Charlotte Brøns, PhD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Low Birth Weight, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Brøns, PhD (+4526129093, charlotte.broens.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content (time frame: 0 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.